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TAP Block: Does Volume Make a Difference?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307215
First Posted: March 2, 2011
Last Update Posted: April 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University
  Purpose
Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Condition Intervention
Post-operative Pain Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume. [ Time Frame: 6 month ]
    This will be shown as a number and a percenttage of patients recruited and randomized.


Secondary Outcome Measures:
  • Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block. [ Time Frame: 48 hours ]
    The assessor will measure the extend of the block distribution at the various time intervals.

  • Pain scores at 2,6,12,24, and 48 hours post-block. [ Time Frame: 48 hours ]
    Using a visual analog scale, patient pain scores will be assessed.

  • Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block. [ Time Frame: 48 hours ]
    Record drug consumption at the time intervals

  • Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours. [ Time Frame: 48 hours ]
  • Block failure rate. [ Time Frame: 48 hours ]
    Block failure rate is defined as the lack of any sensory block following the TAP block.

  • Patient's overall satisfaction. [ Time Frame: 48 hours ]
    Using a LIKERT score, patient satisfaction will be measured.

  • Discharge time from PACU. [ Time Frame: 24 hours ]
    The time in which the patient is discharged from the recovery room.


Enrollment: 31
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20mLs of 0.5% ropivacaine per side Drug: Ropivacaine
20mLs of 0.5%
Other Names:
  • naropeine
  • naropin
Experimental: 30mLs of 0.33% ropivacaine per side Drug: Ropivacaine
30mLs of 0.33%
Other Names:
  • naropeine
  • naropin
Experimental: 40mLs of 0.25% ropivacaine per side Drug: Ropivacaine
40mLs of 0.25%
Other Names:
  • naropeine
  • naropin

Detailed Description:
Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years old
  • total abdominal hysterectomy
  • capable of completing informed consent
  • no previous chronic opioid use
  • no previous abdominal wall surgeries

Exclusion Criteria:

  • patient refusal
  • contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
  • local or systemic infection
  • local anesthetic allergy
  • BMI>35
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307215


Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Mauricio Forero, MD McMaster University/St. Joseph's Healthcare
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01307215     History of Changes
Other Study ID Numbers: 10-3436
First Submitted: February 28, 2011
First Posted: March 2, 2011
Last Update Posted: April 24, 2013
Last Verified: May 2011

Keywords provided by McMaster University:
TAP block
incision pain
total hysterectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents